A Prospective, Multi-Center Study to Evaluate the ConforMIS iUni® G2+ Unicompartmental Knee Resurfacing Device

Restor3D1 site in 1 country28 target enrollmentJuly 15, 2013

ConditionsKnee Osteoarthritis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Knee Osteoarthritis
Sponsor: Restor3D
Enrollment: 28
Locations: 1
Primary Endpoint: 2011 Knee Society Score
Status: Terminated
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is designed to monitor long term clinical outcomes of the iUni G2+ unicompartmental knee replacement

Detailed Description

The study subjects will be followed for 10 years post implant. The follow-up visit schedule will include visits at 6 weeks, 6 months, 1 year, 2 years, 5 years and 10 years post implant.

Registry

clinicaltrials.gov

Start Date

July 15, 2013

End Date

October 14, 2022

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Restor3D

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Clinical condition included in the approved Indications For Use
•Unicompartmental osteoarthritis of the medial or lateral tibiofemoral compartment
•Willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits
•\> 18 years of age

Exclusion Criteria

•Simultaneous bilateral procedure required
•BMI \> 35
•Treatment for cancer within the past 5 years, with the exception of skin cancer
•Poorly controlled diabetes
•Neuromuscular conditions which prevent patient from participating in study activities
•Active local or systemic infection
•Immunocompromised
•Fibromyalgia or other general body pain related condition
•Advanced tricompartmental osteoarthritis
•Symptomatic patellofemoral disease